Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
sodium valproate, Quantity: 40 mg/mL
Sanofi-Aventis Australia Pty Ltd
Oral Liquid
Excipient Ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); sodium methyl hydroxybenzoate; citric acid; brilliant scarlet 4R; hyetellose; sodium propyl hydroxybenzoate; saccharin sodium; Flavour
Oral
300mL
Medicine Registered
(S4) Prescription Only Medicine
Epilepsy: Primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). Partial (focal) epilepsy either alone or as adjuvant therapy. Mania: For the treatment of mania where other therapy has proved inadequate or is inappropriate
Visual Identification: Clear cherry-red slightly viscous liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2000-06-30
EPILIM ® E p i l i m ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING EPILIM? Epilim contains the active ingredient sodium valproate. Epilim is used to treat epilepsy in adults and children. For more information, see Section 1. Why am I using Epilim? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EPILIM? Do not use if you have ever had an allergic reaction to Epilim or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Epilim? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Epilim and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE EPILIM? • Your doctor will tell you how much to take. This may depend on your age, your condition and whether or not you are taking any other medicines. More instructions can be found in Section 4. How do I use Epilim? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING EPILIM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Epilim. • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine. • If you become pregnant while you are taking this medicine, tell your doctor immediately THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly or lower the dosage, without checking with your doctor. • Do not take more than the recommended dose unless your doctor tells you to. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how Epilim affects you. • Children should not ride a bike, climb trees or do anything else that could be d Olvassa el a teljes dokumentumot
epilim-ccdsv31-34-35-piv26-30aug22 Page 1 of 37 AUSTRALIAN PRODUCT INFORMATION EPILIM ® (SODIUM VALPROATE) CRUSHABLE TABLETS, ENTERIC- COATED TABLETS, SYRUP, LIQUID 1 NAME OF THE MEDICINE Sodium valproate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Crushable tablets, Sodium valproate 100 mg. Enteric-coated tablets, Sodium valproate 200 mg. Enteric-coated tablets, Sodium valproate 500 mg. Syrup, Sodium valproate 200 mg/5 mL. Excipients of known effects: sucrose, saccharin sodium and sorbitol. Sugar free liquid, Sodium valproate 200 mg/5 mL. Excipients of known effects: saccharin sodium, sorbitol solution (70%) (non-crystallising), sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Crushable Tablets, 100 mg (white, scored) Tablets, 200 mg (lilac, enteric-coated) Tablets, 500 mg (lilac enteric-coated) Syrup, 200 mg/5 mL (red, cherry flavoured) Sugar free liquid, 200 mg/5 mL (red, cherry flavoured) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _EPILEPSY _ Primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). Partial (focal) epilepsy either alone or as adjuvant therapy. epilim-ccdsv31-34-35-piv26-30aug22 Page 2 of 37 _MANIA _ For the treatment of mania where other therapy has proved inadequate or is inappropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION Epilim tablets may be given twice daily. Uncoated tablets may be crushed if necessary. Epilim Syrup and Sugar-Free Liquid should be given in divided doses. Epilim should preferably be taken with or after food: the enteric-coated tablet (lilac) must be swallowed whole, if necessary with a little water; the plain tablet (white, 100 mg) may be taken whole or crushed and swallowed with water (not aerated). Epilim 500 mg enteric-coated tablets are recommended for patients requiring high doses. Where the possibility of dental caries represents a risk through long-term therapy with Epilim Syrup, it ma Olvassa el a teljes dokumentumot